Quantitative Analysis of Functional Computed Tomography (CT) Imaging of Coronary Atherosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD.
详细描述
Coronary CT angiography (CCTA) has become a reliable diagnostic technique to evaluate coronary artery disease (CAD) with high sensitivity and a negative predictive value. However, CCTA provides only anatomic information and tends to overestimate stenosis severity and is limited in its ability to diagnose myocardial ischemia. Undertaking additional CT myocardial perfusion imaging(CT-MPI) and CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD. SPECT myocardial perfusion imaging (SPECT-MPI)and invasively measured fractional flow reserve (FFR) will serve as the reference standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Understand the purpose of the trial, voluntarily participate in this study, and have signed an informed consent form.
- •Patients with known or suspected CAD
排除标准
- •Patients with acute coronary syndrome.
- •Severe cardiac dysfunction (LVEF ≤ 0.3).
- •Cardiomyopathy with non-coronary causes such as hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, and myocardial amyloidosis.
- •Severe cardiac valve disease with more than moderate valvular regurgitation and/or valvular stenosis.
- •Severe hepatic and renal dysfunction (ALT ≥ 3 Upper Limit of Normal, Cr> 134μ/mol/L (2mg/dl) or estimated Glomerular Filtration Rate<45ml/min/1.73m2).
- •Severe arrhythmias (persistent atrial fibrillation, second-degree or third-degree atrioventricular block, etc.)
- •Malignancy or other pathophysiological conditions with an expected survival of less than 1 year
- •Allergic to the drug components involved in this study and those who are intolerant to loading tests
- •Pregnant or lactating women.
- •Mental disorders.
- •Failure to sign the informed consent form.
- •Other conditions that are incompatible with the clinical study.
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 5 years
including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization.
次要结局
- Diagnostic performance of CT-FFR(From admission to discharge, up to 1 week)
- Diagnostic performance of CT-MPI(From admission to discharge, up to 1 week)